MOSAIQ (UDI 00858164002282)Recalls & reported problems
Elekta Solutions AB · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Elekta MOSAIQ system is the software used to plan and record radiation therapy treatments. The 60 reports mostly describe software problems: treatment data not recorded correctly, values mismatching between MOSAIQ and the treatment console, network disconnections during irradiation, and display or unit discrepancies. No deaths and no injuries are reported. Two recalls name this device; one, started in September 2019 and still open, involves entering metric values into fields labeled with U.S. standard units, and an earlier one from April 2021, since terminated, was about a malware attack.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00858164002282), received between Mar 6, 2020 and Dec 11, 2025 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (60 reports).
2 FDA recall records name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K183034); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 20, 2021Terminated
Malware attack
Z-1783-2021 · Root cause: Under Investigation by firm · FDA record ↗
- Sep 24, 2019Open, Classified
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Z-1597-2020 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem60
- Use of Device Problem2
- Communication or Transmission Problem1
- Installation-Related Problem1
- Intermittent Communication Failure1
Patient problems
- Insufficient Information52
- No Clinical Signs, Symptoms or Conditions47
- No Information7
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A "BEAM ON" HANGING STATUS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23776975 ↗MalfunctionJan 17, 2025Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED INCORRECT VALUES RECORDED IN PATIENT'S TREATMENT CHART.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21178841 ↗MalfunctionJun 6, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THEY HAD TO OVERRIDE GANTRY, BUT THE GANTRY WAS AT THE PRESCRIBED START ANGLE FOR TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19476393 ↗MalfunctionFeb 28, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THEY HAVE IDENTIFIED A COMMUNICATION PROBLEM BETWEEN MOSAIQ AND THE CYBERKNIFE CONTROL CONSOLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18799385 ↗MalfunctionDec 29, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A NETWORK DISCONNECTION DURING IRRADIATION RESULTING IN THE FIELD NOT BEING RECORDED IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18417218 ↗MalfunctionNov 1, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A METERSET UNIT (MU) DISCREPANCY BETWEEN BEAM MONITOR UNIT DISPLAY MODULE (BMDM) AND MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18045552 ↗MalfunctionOct 31, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE NUMERICAL TABLE SHIFT IN MQ AND THE VISUAL MATCH.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18038696 ↗MalfunctionSep 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TREATMENT FIELDS' PARAMETERS IN MOSAIQ AND THE IMPORTED PLANS.
Patient problems: Insufficient Information
MAUDE report 17787438 ↗MalfunctionSep 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TREATMENT FIELDS' PARAMETERS IN MOSAIQ AND THE IMPORTED PLANS.
Patient problems: Insufficient Information
MAUDE report 17787362 ↗MalfunctionSep 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TREATMENT FIELDS' PARAMETERS IN MOSAIQ AND THE IMPORTED PLANS.
Patient problems: Insufficient Information
MAUDE report 17787344 ↗MalfunctionSep 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TREATMENT FIELDS' PARAMETERS IN MOSAIQ AND THE IMPORTED PLANS.
Patient problems: Insufficient Information
MAUDE report 17787323 ↗MalfunctionSep 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TREATMENT FIELDS' PARAMETERS IN MOSAIQ AND THE IMPORTED PLANS.
Patient problems: Insufficient Information
MAUDE report 17787272 ↗MalfunctionSep 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TREATMENT FIELDS' PARAMETERS IN MOSAIQ AND THE IMPORTED PLANS.
Patient problems: Insufficient Information
MAUDE report 17787248 ↗MalfunctionAug 31, 2023Computer Software Problem; Intermittent Communication Failure; Computer Software Problem; Intermittent Communication Failure
THE CUSTOMER REPORTED THAT DISCONNECTIONS ON THE SEQUENCER CAUSED THE DELIVERED TREATMENT TO FAIL TO RECORD IN MOSAIQ.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 17660803 ↗MalfunctionAug 31, 2023Computer Software Problem; Computer Software Problem
" THE CUSTOMER REPORTED THAT DISCONNECTIONS ON THE SEQUENCER CAUSED THE DELIVERED TREATMENT TO FAIL TO RECORD IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17660733 ↗MalfunctionJul 21, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE ISOCENTER FOR CBCT FOR IMAGING WAS DIFFERENT THAN THE ACTUAL TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17370354 ↗MalfunctionJun 16, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED DURING A VMAT TREATMENT EXECUTION.
Patient problems: Insufficient Information
MAUDE report 17141608 ↗MalfunctionJun 7, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A COMMUNICATION TIMEOUT WITH MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17077888 ↗MalfunctionMay 24, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A COMMUNICATION TIMEOUT WITH MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16990556 ↗MalfunctionMay 24, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A COMMUNICATION TIMEOUT WITH MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16990517 ↗MalfunctionMay 5, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THERE WAS NO TREATMENT REGISTRATION FOR A PARTIAL TREATMENT FOR A SPECIFIC PATIENT.
Patient problems: Insufficient Information
MAUDE report 16874603 ↗MalfunctionApr 26, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ DID NOT RECORD THE TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16815671 ↗MalfunctionApr 26, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ DID NOT RECORD THE TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16815322 ↗MalfunctionApr 13, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ DID NOT RECORD THE TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16731575 ↗MalfunctionApr 12, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ DID NOT RECORD THE THERAPY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16724781 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K183034. One submission often covers many models, so check the product and lot details in each record.
- Z-2591-2021 · Sep 2, 2021 · Open, ClassifiedMOSAIQ Oncology Information System
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.